Deskripsi Pekerjaan
Are you a detail-oriented Chemical Engineer seeking to contribute to a world-class pharmaceutical operation? Am-Europharma Corporation is looking for a dedicated Technical Services Specialist to support our manufacturing excellence. In this critical role, you will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) through rigorous validation and documentation processes.
As part of our technical team, you will oversee equipment qualification (IQ, OQ, PQ), manage deviation investigations, and maintain comprehensive technical documentation. We are looking for a proactive professional who can bridge the gap between engineering and operations to drive continuous improvement in our production lines. Your expertise will ensure that all manufacturing equipment meets stringent safety and quality standards, directly impacting product integrity and patient safety. This position requires a strong understanding of process validation, change control, and troubleshooting. If you are passionate about quality assurance and possess a strong technical background, we encourage you to apply and become a key player in our mission to deliver high-quality healthcare solutions to the community. We offer a dynamic work environment where your technical skills are valued and opportunities for growth are abundant. Join us in Calamba City, Laguna, and take the next step in your career.
Tanggung Jawab
- Conduct and manage Equipment Qualification (IQ, OQ, PQ) activities and technical documentation.
- Perform routine and validation-related investigations to identify root causes of deviations.
- Prepare and maintain standard operating procedures (SOPs), batch records, and change controls.
- Support internal and external regulatory audits, ensuring 100% documentation compliance.
- Coordinate with maintenance and production teams to resolve technical equipment issues.
- Assist in the development and implementation of technical systems and validation protocols.
- Ensure all technical processes adhere to local and international regulatory standards.
Kualifikasi
- Bachelor’s degree in Chemical Engineering or related technical field.
- Minimum of 3-5 years of experience in pharmaceutical or chemical manufacturing, preferably in QA/QC or Validation.
- In-depth knowledge of GMP, GLP, and validation principles.
- Strong proficiency in document control, root cause analysis, and CAPA management.
- Excellent written and verbal communication skills for technical reporting.
- Ability to work collaboratively in a fast-paced manufacturing environment.